The approval allows using XIENCE stent for a shorter duration of DAPT as short as 28 days to treat high bleeding risk patients
Healthcare company Abbott has secured CE mark approval for its XIENCE stent for one-month dual anti-platelet therapy (DAPT) for high bleeding risk patients.
The approval allows using XIENCE stent for a shorter duration of DAPT as short as 28 days to treat patients with high bleeding risk (HBR).
The CE mark approval for the stent follows the results from two studies, which have shown both one-month or three-month DAPT followed by aspirin monotherapy is safe in HBR patients.
XIENCE is said to be the only stent to have evidence and data for both one-month and three-months DAPT followed by two different types of blood-thinning medication in HBR patients.
Abbott had recruited over 3,600 participants from Europe, the Americas and Asia in XIENCE 28 and XIENCE 90 clinical trials.
Two different DAPT durations, including one-month and three-months, have been monitored by the studies exclusively in HBR patients.
The studies showed that DAPT can be safely discontinued early – as short as 28 days – with no increased risk in patient adverse events.
The company said that the studies further confirmed the safety profile of the XIENCE stent.
Abbott’s vascular business global medical affairs divisional vice president and chief medical officer Dr Nick West said: “In patients with high bleeding risk, the XIENCE stent has proven that it can ensure patient safety without compromising efficacy when duration of blood-thinning medications is shortened.
“These findings build on the unrivalled volume of research confirming the XIENCE stent’s leading performance across a range of patient and clinical situations.”
Abbott has carried out clinical research required to assess the safety of the XIENCE stent in patients using a shorter DAPT duration. It is designed to mainly use in life-saving treatments that can help prevent or treat heart attacks.
In addition, the company is seeking an indication for HBR for the XIENCE stent in the US.